The present invention relates to a method for human sterilization, and more particularly to a method for sterilization of the male by coagulation of the vas.
Tubal ligation instruments have found worldwide acceptance for a variety of purposes but in particular have been used for sterilization of the male. In many areas of the world the question of population control has become an essential issue, and such instruments have found wide utilization.
In the U.S. Pat. No. 3,834,392, granted to Lampman et al on Sept. 10, 1974, there is disclosed a laparoscope system for sterilization whereby a single unit contains the power source to provide illumination, oscillatory electrical power, and CO.sub.2 gas for laparoscopy. The CO.sub.2 gas under pressure is first passed into the body through a needle into the peritoneal cavity. A trocar and cannula are inserted into the gas-filled abdominal cavity. A telescope connected to a source of illumination is inserted into the body cavity through the cannula. The anatomical tubes are then identified through the laparoscope. Flexible forceps are thereafter inserted through the laparoscope into the body cavity. The forceps are manipulated to successively close the passage through each tube either by means of sending electrical oscillation through the forceps to simultaneously cut, seal, and cauterize each tube in turn, of by means of a specific clamp, which clamps the passage shut.
Also, a ring applicator device is disclosed in U.S. Pat. No. 3,989,049 to In Bae Yoon, granted on Nov. 2, 1976. The Yoon device is used for applying an elastic occluding ring to an anatomical tubular structure. The Yoon device comprises an inner cylinder slidably disposed within an outer cylinder, forceps means slidably disposed within said inner cylinder, means for moving said forceps means into and out of the inner cylinder and means for ejecting an elastic ring from the end of said inner cylinder by axially displacing said outer and inner cylinders relative to each other.
Heretofore, male sterilization by the use of clamps or elastic rings has been quite popular, however, there are certain inconveniences and dangers associated with elastic ring sterilization. This type of sterilization usually requires some cutting of the patient accompanied by a period of hospitalization. Furthermore, in any type of medical procedure requiring incision there is always the possibility and danger of infection.
Another technique used in the sterilization of the male is that of electro-surgery. Electro-surgery involves conducting a high frequency current, typically a radio-frequency current to the male vas in a manner to burn off certain portions of the tubes.
The method of electro-surgery heretofore used has involved an electrocautery apparatus operated with a monopolar current flow, in which the forceps conduct a radio frequency current (RF) from the source to the anatomical tube, after which the current flows from the anatomical tube through the patient's body to an electrode strapped on the patient's leg or elsewhere and thereafter to the ground.
Again, this procedure may also require some period of hospitalization. Furthermore, there have been other difficulties encountered in electro-surgery. For example, if the electrical path between the patient's body and ground should be poor or if it should be broken for any reason, the patient is frequently burned on whatever part of his body might be touching or close to the operating table, since the high frequency energy will seek the shortest path to the ground. Also, electro-surgery tends to dry out the effective tissue, thus cutting off the possible path of electrical current. With the current path cut off, current flow occurs in random directions away from the operation site, and thus causes burns of other tissue adjacent to the anatomical tube being treated.
In both of the above discussed sterilization techniques, parts of the body other than those which are to be treated may be burned, cut, or damaged.
It is accordingly an object of this invention to provide a means for accomplishing male sterilization and to avoid the problems of the techniques heretofore used.
It has surprisingly been discovered that male sterilization can be accomplished, without the need for incision or cauterization and their accompanying inconveniences and dangers, by the use of the method of the present invention. In utilizing the apparatus of the present invention, a surgeon exposes the anatomical element to be treated to electromagnetic radiation which is absorbed by the element causing the element to rise in temperature to a sufficient degree for coagulation thereof. In utilizing the present invention, for example in sterilizing the male vas, the surgeon would grasp that portion of skin to which the vas is closely adjacent and thereby manipulate the skin around the vas. The vas and the surrounding skin are disposed in the sterilization apparatus and exposed to electromagnetic radiation for coagulation of the vas. This procedure involves no incision or cauterization nor is there any damage to the grasped skin or any adjacent body elements. Since such a sterilization procedure requires no healing period, e.g. healing of an incision, and is itself relatively simple, no extended time in the hospital is needed. Thus, the method of the present invention does provide a very significant advancement in the field of sterilization.
Treatment with electromagnetic radiation has in recent years found applications in the treatment of cancerous organs. In such treatment, electromagnetic radiation impinges the body and is directed towards the cancerous tissue. Some of the electromagnetic radiation will be attenuated as it travels through the body to the cancerous tissue. Depth of radiation penetration into the body is a function of the radiation frequency as well as tissue absorption. The amount of radiation absorbed by tissue is dependent on the chemical composition of the tissue. Thus, the composition of both the cancerous tissue as well as the tissue through which the radiation passes in reaching the cancerous tissue must be known and understood.
With the proper frequency selected for the particular tissue to be treated, the electromagnetic radiation penetrates the body and is substantially absorbed by both normal and cancerous tissue. However the cancerous tissue reacts differently than the normal tissue and is more readily affected or destroyed. The tolerance of internal organs of mammals to temperature change is very limited. An elaborate biological mechanism exists to maintain the internal temperature of hot-blooded animals within well defined limits. In typical cancer treatment, to which we make reference, the tissue temperature is usually raised about 5 or 6 degrees. This rise in tissue temperature does not cause any permanent damage. Normally the body organs are at about 38.degree. C., and in such treatment are typically raised to a temperature of about 44.degree. C. It has been discovered that this small elevation in tissue temperature often results in either the retarding of the cancerous growth or its self-destruction.
To the present time, radiation exposure has primarily focused on cancer treatment. In such application the radiation must be of a frequency which can penetrate deep into the body. Furthermore, such treatment is directed to relatively large areas of tissue which are raised only a few degrees in temperature by radiation exposure.
The method of the present invention deviate from the major thrust of most radiation treatment. The present invention is concerned with changing or destroying the chemical and/or cell structure of relatively small areas of the body, and furthermore, utilizes electromagnetic radiation at a higher frequency than heretofore used, resulting in relatively shallow radiation penetration through the tissue with selective heating effect of fatty and muscular tissue. These and other objects are accomplished by the method of the present invention in selective applications for example, male sterilization by coagulation of the vas.